Home Europe European Parliament Decision (EU) 2024/2306 of the European Parliament of 11 Apr...
Date: 10-Oct-2024 Category: Not Applicable State: Union Government Country: Europe

Decision (EU) 2024/2306 of the European Parliament of 11 April 2024 on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2022

Issued by European Parliament · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • The European Parliament has granted discharge to the Executive Director of the European Medicines Agency (EMA) regarding the implementation of the agency's budget for the financial year 2022. This means the Parliament approves how the EMA managed its finances during that period.

Key Changes

  • The European Parliament, after reviewing the EMA's financial accounts, the Court of Auditors' report, and the Council's recommendation, has formally approved the EMA's budget implementation for 2022.
  • The decision is based on Article 319 of the Treaty on the Functioning of the European Union and other relevant regulations, including Regulation (EU, Euratom) 2018/1046 and Regulation (EC) No 726/2004.
  • The Parliament's observations are detailed in a separate resolution that forms an integral part of the discharge decision.
  • The decision instructs the President of the Parliament to forward the decision and resolution to the EMA's Executive Director, the Council, the Commission, and the Court of Auditors, and to publish them in the Official Journal of the European Union.

Impact Analysis

European Medicines Agency (EMA)

  • Action Item: The Executive Director should review the resolution accompanying the discharge decision to address any observations or recommendations made by the Parliament.

European Parliament

  • Action Item: The Committee on Budgetary Control should continue to monitor the EMA's financial performance and implementation of recommendations.

Council of the European Union

  • Action Item: The Council should take note of the Parliament's decision and any related observations.

Court of Auditors

  • Action Item: The Court of Auditors should continue to audit the EMA's financial accounts and report its findings to the Parliament and Council.

European Commission

  • Action Item: The Commission should take note of the Parliament's decision and ensure the EMA's future budget implementation aligns with EU financial regulations.

Stakeholders of the EMA (e.g., pharmaceutical companies, patients)

  • Indirectly affected: The discharge decision provides assurance that the EMA is operating with sound financial management, which is crucial for maintaining trust and confidence in the agency's regulatory activities.

Key Entities Referenced

European Medicines Agency (EMA): A decentralised agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. European Parliament: The directly elected parliamentary body of the European Union with legislative, supervisory, and budgetary responsibilities. Council of the European Union: A component of the EU legislature where ministers from each national government meet to adopt laws and coordinate policies. Court of Auditors: The EU's independent external auditor, responsible for auditing the EU's finances. European Commission: The executive branch of the European Union, responsible for proposing legislation, implementing decisions, and managing the EU's budget. Treaty on the Functioning of the European Union: One of the primary treaties forming the constitutional basis of the European Union. Regulation (EU, Euratom) 2018/1046: Regulation on the financial rules applicable to the general budget of the Union. Regulation (EC) No 726/2004: Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency. Commission Delegated Regulation (EU) 2019/715: Framework financial regulation for the bodies set up under the TFEU and Euratom Treaty.
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Official Journal EN of the European Union L series 2024/2306 10.10.2024 DECISION (EU) 2024/2306 OF THE EUROPEAN PARLIAMENT of 11 April 2024 on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2022 THE EUROPEAN PARLIAMENT, — having regard to the final annual accounts of the European Medicines Agency for the financial year 2022, — having regard to the Court of Auditors’ annual report on EU agencies for the financial year 2022, together with the agencies’ replies(1), — having regard to the statement of assurance(2)as to the reliability of the accounts and the legality and regularity of the underlying transactions provided by the Court of Auditors for the financial year 2022, pursuant to Article 287 of the Treaty on the Functioning of the European Union, — having regard to the Council’s recommendation of 22 February 2024 on discharge to be given to the Agency in respect of the implementation of the budget for the financial year 2022 (06180/2024 – C9-0094/2024), — having regard to Article 319 of the Treaty on the Functioning of the European Union, — having regard to Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012(3), and in particular Article 70 thereof, — having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency(4), and in particular Article 68 thereof, — having regard to Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council(5), and in particular Article 105 thereof, — having regard to Rule 100 of and Annex V to its Rules of Procedure, — having regard to the opinion of the Committee on the Environment, Public Health and Food Safety, — having regard to the report of the Committee on Budgetary Control (A9-0133/2024), 1. Grants the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2022; 2. Sets out its observations in the resolution below; 3. Instructs its President to forward this decision, and the resolution forming an integral part of it, to the Executive Director of the European Medicines Agency, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series). The President The Secretary-General Roberta METSOLA Alessandro CHIOCCHETTI (1) OJ C, C/2023/594, 27.10.2023. (2) OJ C, C/2023/112, 12.10.2023. (3) OJ L 193, 30.7.2018, p. 1. (4) OJ L 136, 30.4.2004, p. 1. (5) OJ L 122, 10.5.2019, p. 1. ELI: http://data.europa.eu/eli/dec/2024/2306/oj 1/1

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